UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020685 |
|---|---|
| Receipt number | R000023866 |
| Scientific Title | Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis? |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/07/24 18:45:44 |
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Basic information
Public title
Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Acronym
Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Scientific Title
Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Scientific Title:Acronym
Could the effect of nutrition therapy on microbiota contribute to long term clinical outcome in patients with ulcerative colitis?
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate whether or not the effect of nutrition therapy on microbiota could contribute to long-term clinical outcome of ulcerative colitis patients with mucosal healing prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of nutrition therapy on microbiota
Key secondary outcomes
1.The involvement of microbiota after nutrition therapy in clinical outcome of patients with ulceartive colitis after achieving mucosal healing.
2.The involvement of the change of diet in transition of microbiota
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
nutrition counselling: For patients with ulcerative colitis, a questionnaire survey of diet will be performed. Four weeks after first survey, second survey will be performed for evaluating the effect of nutrition counselling. We will evaluate the microbiota with T-RFLP analysis at 1st and 2nd survey.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Ulcerative colitis patient with complete remission
2. Patient without treament with antibiotics one month before participating this clinical study
3. Patient without infectious enterocolitis
Key exclusion criteria
1. Pregnant woman or woman with possibility of pregnancy
2. Patient who were impossible to perform colonoscopy
3. Patient with malignancy
4. Patient with stoma
5. Patient with a history of intestinal resection for three months
6. Patient who were unsuitable for this study by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Yoshino |
Organization
Kitano Hospital
Division name
Digestive Disease Center
Zip code
Address
2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
t-yoshino@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Yoshino |
Organization
Kitano Hospital
Division name
Digestive Disease Center
Zip code
Address
2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
t-yoshino@kitano-hp.or.jp
Sponsor or person
Institute
Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitano Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2018 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023866
